Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    FID21
Previous Study | Return to List | Next Study

Influenza Vaccine Revaccination in Ambulatory Elderly Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00775450
Recruitment Status : Completed
First Posted : October 20, 2008
Results First Posted : August 11, 2011
Last Update Posted : December 31, 2013
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE October 16, 2008
First Posted Date  ICMJE October 20, 2008
Results First Submitted Date  ICMJE July 14, 2011
Results First Posted Date  ICMJE August 11, 2011
Last Update Posted Date December 31, 2013
Study Start Date  ICMJE October 2008
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2011)
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection [ Time Frame: Days 0 through 7 post vaccination ]
Solicited injection site reactions: Pain, Erythema (redness), Swelling, Induration, Ecchymosis, Pruritus. Solicited systemic reactions: Fever, (Temperature), Headache, Malaise, Myalgia, and Shivering.
Original Primary Outcome Measures  ICMJE
 (submitted: October 16, 2008)
  • Safety: To provide information concerning the safety after revaccination with influenza vaccine [ Time Frame: 28 days post vaccination and entire study duration ]
  • Immunogenicity: To provide information concerning the immune response of Influenza vaccine [ Time Frame: 28 days post-vaccination ]
Change History Complete list of historical versions of study NCT00775450 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2011)
  • Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection [ Time Frame: Day 0 and Day 28 post-vaccination ]
    Serum antibody titers for the influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by the hemagglutinin inhibition (HAI) assay.
  • Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine [ Time Frame: Days 0 and 28 post-vaccination ]
    Seroprotection was defined as hemagglutinin inhibition (HAI) titer ≥ 1:40 at Day 28.
  • Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine [ Time Frame: Day 28 post vaccination ]
    Seroconversion was defined as either a pre-vaccination hemagglutinin inhibition (HAI) titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre- vaccination titer ≥ 1:10 and a minimum 4 fold increase at 28 days post vaccination.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Influenza Vaccine Revaccination in Ambulatory Elderly Subjects
Official Title  ICMJE Safety and Immunogenicity of Revaccination With Influenza Vaccine in Ambulatory Elderly Subjects Previously Vaccinated With Fluzone ID, Fluzone HD, and Fluzone® IM
Brief Summary

This is a multi-center study designed to evaluate the safety and immunogenicity of a Fluzone revaccination in elderly adults aged ≥ 65 years.

Primary Objective:

To describe the safety profile for all subjects.

Secondary Objective:

To describe immunogenicity 28 days following revaccination with one of three Fluzone formulations.

Detailed Description Subjects who previously participated in study FID29 will be invited to participate in this revaccination study. They will be assigned to 1 of 3 groups based on the group they were previously randomized to and the vaccine received in study FID29.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Influenza
  • Orthomyxovirus Infection
  • Myxovirus Infection
Intervention  ICMJE
  • Biological: Influenza Virus Vaccine USP Trivalent Types A and B
    0.1 mL, Intradermal
    Other Name: Fluzone
  • Biological: Influenza Virus Vaccine USP Trivalent Types A and B
    0.5 mL, Intramuscular
    Other Name: Fluzone
Study Arms  ICMJE
  • Experimental: Group 1a: Fluzone ID After Fluzone ID
    Intervention: Biological: Influenza Virus Vaccine USP Trivalent Types A and B
  • Experimental: Group 1b: Fluzone IM After Fluzone ID
    Intervention: Biological: Influenza Virus Vaccine USP Trivalent Types A and B
  • Active Comparator: Group 2a: Fluzone IM After Fluzone IM
    Intervention: Biological: Influenza Virus Vaccine USP Trivalent Types A and B
  • Experimental: Group 2b: Fluzone ID After Fluzone IM
    Intervention: Biological: Influenza Virus Vaccine USP Trivalent Types A and B
  • Active Comparator: Group 3: Fluzone HD After Fluzone HD
    Intervention: Biological: Influenza Virus Vaccine USP Trivalent Types A and B
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 8, 2010)
807
Original Estimated Enrollment  ICMJE
 (submitted: October 16, 2008)
1200
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria :

  • Aged ≥ 65 years on the day of vaccination
  • Enrolled in and completed study FID29 and received the correct vaccine for the group to which they were randomized
  • Informed consent form signed and dated
  • Able to attend all scheduled visits and to comply with all trial procedures
  • Subject is medically stable.

Exclusion Criteria :

  • Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
  • Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the four weeks preceding the trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
  • Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
  • Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
  • Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response
  • Receipt of any vaccination in the 4 weeks preceding the trial vaccination
  • Planned receipt of any vaccine in the 4 weeks following the trial vaccination
  • Known human immunodeficiency virus (HIV), hepatitis B (HBs) antigen, or Hepatitis C seropositivity.
  • Previous vaccination against influenza in the past 6 months with the trial vaccine or another vaccine
  • Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular (IM) vaccination
  • Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
  • Neoplastic disease or any hematologic malignancy, (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy, as well as subjects who have a history of neoplastic disease and who have been disease free for ≥ 5 years).
  • Personal or family history of Guillain-Barré Syndrome.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00775450
Other Study ID Numbers  ICMJE FID21
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Sanofi Pasteur Inc.
PRS Account Sanofi
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP